Phase 1 Leukaemia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are willing to take part, have read and signed the consent form, and are able to follow all study procedures.
• You are between 18 and 74 years old (inclusive), of any gender.
• You have been diagnosed with acute myeloid leukemia (AML), including AML that developed from another blood condition, based on 2022 WHO standards.
• Your AML has come back after treatment (relapsed) or has not responded to treatment (refractory), following specific patterns — or you have received up to 3 additional cycles of chemotherapy or targeted therapy since your relapsed/refractory diagnosis (confirm with trial site for which category applies to you).
• Your general health and ability to carry out daily activities is at a certain level, as measured by a standard medical score (ECOG score of 2 or lower).
• If you are of childbearing age, you and your partner agree to use effective birth control and not plan a pregnancy for 6 months after your last dose of the study drug.
• Your doctors expect you to live for at least 3 more months.

Who may not be able to join:

• You have a specific type of leukemia called acute promyelocytic leukemia.
• You have chronic myeloid leukemia that has turned into a blast crisis.
• You have leukemia that has spread to your central nervous system (brain and spinal cord) and is causing symptoms.
• You have previously had a stem cell transplant from a donor (allogeneic), or any other organ transplant.
• You had a stem cell transplant using your own cells (autologous) less than 3 months before starting the trial.
• You have previously received certain immune cell-based therapies such as CAR-T, CAR-NK, or TCR-T cell therapy.
• You have received cancer treatments (other than a specific medication called hydroxyurea) within the 2 weeks before starting the trial.
• You have had another cancer in the past 3 years, except for certain fully treated skin cancers or carcinoma in situ.
• You have a very high number of leukemia cells (blasts) in your blood above a certain level, unless this can be controlled with hydroxyurea first.
• Your liver, kidney, or blood clotting test results are outside certain acceptable ranges (confirm with trial site for specific values).
• You have had certain heart problems in the past 6 months, including serious heart rhythm issues, heart failure (NYHA Grade 3 or above), unstable chest pain, a heart attack, a weakened pumping function, or significant fluid around the heart.
• You have an autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus) that has required ongoing immune-suppressing medication within the past 2 years.
• You have active hepatitis B, active hepatitis C, or HIV.
• You are pregnant or currently breastfeeding.
• You have had major surgery within 28 days before starting the trial.
• You have a history of alcohol or drug misuse in the past year.
• You have taken part in another clinical trial and received an unapproved investigational treatment within the past 4 weeks.
• You are known to be allergic to the main ingredients of the study drug.
• You have other serious health conditions or abnormal test results that could make participation risky or affect the study results (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.